FDA Approves Revlimid® and Rituximab Combo for FL and MZL

The U.S. Food and Drug Administration approved Revlimid® (lenalidomide) in combination with rituximab for previously-treated follicular lymphoma (FL) and marginal zone lymphoma (MZL). The approval was based on findings from two clinical trials: AUGMENT and MAGNIFY.

Improved survival with lenalidomide and rituximab combo

In the AUGMENT trial, 358 patients with relapsed/refractory FL or MZL were randomized 1:1 to receive lenalidomide and rituximab or rituximab and placebo. Median progression-free survival (primary endpoint) was 39.4 months (95% CI, 22.9 to not estimable) in the lenalidomide plus rituximab arm and 14.1 months (95% CI, 11.4-16.7) in the rituximab and placebo cohort (hazard ratio = 0.46; 95% CI, 0.34-0.62; P<0.0001). The objective response rate (ORR) for those with FL was 80% (n=118/147; 95% CI, 73-86) in the lenalidomide plus rituximab group compared with 55.4% (n=82/148; 95% CI, 47-64) in the rituximab and placebo arm. The ORR for patients with MZL was 65% (n=20/31; 95% CI, 45-81) and 44% (n=14/32; 95% CI, 26-62), respectively.

In the single-arm component of the MAGNIFY study, 232 patients with relapsed/refractory FL, MZL, or mantle cell lymphoma received 12 induction cycles of lenalidomide and rituximab. The ORR was 59% (n=104/177; 95% CI, 51-66) for patients with FL and 51% (n=23/45; 95% CI, 36-66) for patients with MZL. Median response duration was not reached for patients with FL or MZL after a median follow-up of 7.9 months (95% CI, 4.6-9.2) and 11.5 months (95% CI, 8.0-18.9), respectively.

In both trials, the most common adverse events were neutropenia, fatigue, diarrhea, constipation, nausea, and cough.


The prescribing information for Revlimid® carries a Boxed Warning alerting healthcare professionals and patients about the risk of embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism, which may be life-threatening or fatal.

The recommended lenalidomide dose for FL or MZL is 20 mg once daily orally on days one to 21 of repeated 28-day cycles for up to 12 cycles.